Eisai Zonegran extended license application gets EMA acceptance
Eisai has received the European Medicines Agency (EMA) acceptance for reviewing its license extension application for the usage of the company's antiepileptic drug Zonegran (zonisamide) as a monotherapy, which was earlier approved as an adjunctive therapy.
With this license extension application, the company is seeking marketing approval from the EMA for Zonegran as a monotherapy for patients suffering from epilepsy with partial seizures, with and without secondary generalization.
The submission of the application was done on the basis of a multicenter, double-blind, randomized study comparing daily zonisamide with twice-daily controlled release carbamazepine as monotherapy.
The study involved around 583 adult patients with newly diagnosed partial-onset epilepsy.
The results of the trial suggested that zonisamide was effective and well tolerated when used as a monotherapy in newly diagnosed epilepsy patients.
Related Insight
Suppliers Directory
Pharmalink Consulting - Regulatory Affairs Consultancy
We provide Regulatory Affairs support services to Healthcare companies globally. Our services cover the full product life-cycle, from pre-approval to licence maintenance and compliance activities. Our Clients benefit from our top-quality interim Regulatory Affairs staffing solutions and Consultancy Services.
Regulatory Affairs > Suppliers
Production & Manufacturing
Fine & Speciality Chemicals
Manufacturing
Process & Production
OTC
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Regulatory Affairs Intelligence
Implementing Rapid Microbiology Methods
Published by Parenteral Drug Association (PDA)
Regulatory Affairs > White Papers
International Product Law Manual
Published by Jardine Lloyd Thompson Limited
Regulatory Affairs > White Papers
Efficacy and Surgical Research Services (ESRS)
Published by Toxikon Europe
Regulatory Affairs > White Papers
Buy the latest industry research online today!
Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential
GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Buy online from $3500
GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Buy online from $3500
Comments may be moderated for spam, obscenities or defamation.